Self-contained auto-injector

ABSTRACT

A drug self-delivery device comprising a body portion containing a drug vial and a needle assembly, where the body portion is slidably engaged to a trigger portion. When engaged by a user pressing the trigger portion against the user&#39;s flesh, the needle assembly relative to the drug vial so as to align a needle port with an integral drug delivery port connected to the drug vial thereby allowing fluid flow of medication through the needle. Seals engaged by a penetration spring prevent loss of medication and prevent the need for direct connection between the needle assembly and the drug vial.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.15/790,263, filed Oct. 23, 2017, which claims the benefit under 35U.S.C. § 119(e) of U.S. Provisional Application Ser. No. 62/414,871filed on Oct. 31, 2016, and U.S. Provisional Application Ser. No.62/455,241 filed on Feb. 6, 2017, the entire disclosure of each of whichis incorporated herein by reference.

TECHNICAL FIELD

The present invention relates to autoinjectors and in particular to awearable autoinjector having a needle assembly and a drug vial arrangedside by side.

BACKGROUND

Ingesting, inhaling, and/or injecting certain allergens, toxins, and/orother substances can cause profound reactions for at least some and/orall people and/or animals. For example, certain people are highlyallergic to certain substances, such as peanuts, shellfish, particulardrugs, certain proteins, bee venom, insect bites, etc. The allergicresponse can lead to anaphylactic shock, which can cause a sharp drop inblood pressure, hives, and/or substantial breathing difficulties causedby severe airway constriction. As another example, inhalation of certainnerve agents can cause severe physiological trauma. Responding rapidlyto such exposures can prevent injury and/or death. For example, inresponse to an exposure leading to anaphylactic shock, an injection ofepinephrine (i.e., adrenaline) can provide substantial and/or completerelief from the reaction. As another example, injection of an antidoteto a nerve agent can greatly reduce and/or eliminate the potential harmof the exposure. As yet another example, rapid injection of certaindrugs, such as a beta blocker, blood thinner, nitroglycerine,antihistamines, insulin, and opioids, etc., can provide substantialrelief from various dangerous medical conditions.

An autoinjector is a medical device designed to deliver one or moredoses of a particular drug in a manner that facilitatesself-administration of the drug via a syringe. By design, autoinjectorsare easy to use and are intended to be used by patients or by untrainedpersonnel. They typically are self-contained and designed to requireonly a few basic steps to operate.

SUMMARY

It is a challenge to package components into a form factor that allows auser to wear a medical device. The medical device can include a syringe,a drug dose, and a source of stored energy needed to auto-inject thedose into the user. A solution to the challenge is a wearable drugdelivery device with a needle assembly and a drug vial containing a drugdose arranged side-by-side.

An exemplary wearable drug delivery device includes a handheld portion,including a proximal end, a distal end, and a longitudinal axisextending between the proximal and distal ends. The wearable drugdelivery device further includes a trigger portion in slidableengagement with the distal end of the handheld portion and a needleassembly disposed within the handheld portion and aligned with thelongitudinal axis. The needle assembly being movable towards the distalend of the handheld portion to an extended position by a penetrationspring when the penetration spring is activated by the trigger portionsliding towards the proximal end of the handheld portion. The wearabledrug delivery device further includes a drug vial disposed within thehandheld portion alongside the needle assembly. The drug vial ismoveable towards the distal end of the handheld portion to a seatedposition by a vial spring when the vial spring is activated by thetrigger portion sliding towards the proximal end of the handheldportion. The wearable drug delivery device further includes an integraldrug delivery port formed at the distal end of the handheld portion andtransverse to the longitudinal axis of the handheld portion. The needleassembly in the extended position and the drug vial in the seatedposition are in fluid communication with each other by way of theintegral drug delivery port.

The handheld portion of the wearable drug delivery device can include aconcave surface, the concavity of which is defined by a point offsetfrom the longitudinal axis. The concave surface can be configured toconform to the human wrist.

The handheld portion of the wearable drug delivery device can include aslot. The wearable drug delivery device can further include a band thatis received in the slot for wearing the wearable drug delivery devicearound a part of a user's body.

The handheld and trigger portions of the wearable drug delivery devicecan be made from a metal, a plastic or a combination of metal andplastic.

The trigger portion of the wearable drug delivery device can slide overthe distal end of the handheld portion.

The trigger portion of the wearable drug delivery device can include atrigger arm extending from the trigger portion and through the distalend of the handheld portion. The trigger arm is configured to releaseenergy stored in the penetration spring when the trigger portion slidestoward the proximal end of the handheld portion. The trigger portion ofthe wearable drug delivery device can include two trigger arms.

The wearable drug delivery device can further include a rotator coupledto the drug vial. The rotator and the drug vial are urged towards thedistal end of the handheld portion by the vial spring. The wearable drugdelivery device can further include a yoke extending from the distal endof the handheld portion towards the proximal end. The rotator rests onthe yoke thereby resisting movement toward the distal end of thehandheld portion and moving the drug vial to the seated position. Thetrigger portion can include a trigger blade extending from the triggerportion and through the distal end of the handheld portion. The triggerblade is in slidable engagement with the rotator and is configured tolift the rotator off the yolk and allow the rotator to move towards thedistal end of the handheld portion and move the drug vial to the seatedposition when the trigger portion slides toward the proximal end of thehandheld portion.

The trigger blade of the wearable drug delivery can include an angledsurface to lift and turn the rotator off the yoke. The trigger portionof the wearable drug delivery device can include three trigger blades.

The needle assembly of the wearable drug delivery device can include aJ-shaped needle.

The integral drug delivery port of the wearable drug delivery device caninclude a vial needle, an exit, and a channel connecting the vial needleto the exit. The vial needle punctures a vial membrane of the drug vialwhen the drug vial is in the seated position thereby allowing a drugdose to flow through the channel and out the exit. The exit can be aseptum seal that is pierced by the needle assembly when the needleassembly is in the extended position.

The wearable drug delivery device can further include a return springinterposed between an exterior surface at the distal end of the handheldportion and an opposing surface on the trigger portion. The returnspring provides a force separating the handheld portion from the triggerportion. The wearable drug delivery device can further include a latchextending from the opposing surface of the trigger portion andreleasable engaged with the handheld portion. The latch when engagedresists the force separating the handheld portion from the triggerportion. The latch can be a leaf spring. The return spring can be atorsion spring.

The wearable drug delivery device can further include a safety guardthat covers the trigger portion and is releaseably attached to thehandheld portion by any one of an interference fit and a frangible weldjoint.

The wearable drug delivery device can further include a safety guardcovering the trigger portion and releaseably attached to the handheldportion. The wearable drug delivery device can further include a stripdisposed circumferential between the handheld portion and the safetyguard. The strip is configured to be torn away from the handheld portionand the safety guard thereby allowing the safety guard to be removedfrom the handheld portion and expose the trigger portion.

The handheld portion of the wearable drug delivery device has anexterior surface parallel to the longitudinal axis. The wearable drugdelivery device can further include a one-way barb projecting from theexterior surface of the handheld portion and a snap feature joined tothe trigger portion by a virtual hinge. When the trigger portion slidestoward the proximal end of the handheld portion, the snap feature slidesover the exterior surface of the handheld portion and flexes about thevirtual hinge, away from the exterior surface, when the snap featureslides over the one-way barb.

BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing and other objects, features and advantages will beapparent from the following more particular description of the examples,as illustrated in the accompanying drawings in which like referencecharacters refer to the same parts throughout the different views. Thedrawings are not necessarily to scale, emphasis instead being placedupon illustrating the principles of the examples.

FIG. 1 is perspective view of an example wearable drug delivery device.

FIG. 2 is a cut-away view of the wearable drug delivery device of FIG.1.

FIG. 3 is a close up view of an example integral drug delivery port ofthe wearable drug delivery device of FIG. 1.

FIGS. 4A and 4B are perspective views of an example needle assembly ofthe wearable drug delivery device of FIG. 1.

FIG. 4C is a cut-away view of the wearable drug delivery device of FIG.1 with the needle assembly in the extended position.

FIGS. 5A-C is a series of views of a drug delivery sequence of thewearable drug delivery device of FIG. 1.

FIGS. 6A-C are views of example components of a needle trigger mechanismof the wearable drug delivery device of FIG. 1.

FIGS. 6D-G is a series of views of the operation of the needle triggermechanism of the wearable drug delivery device of FIG. 1.

FIGS. 7A-7C are views of example components of a delivery triggermechanism of the wearable drug delivery device of FIG. 1.

FIGS. 8A-D is a series of views of the operation of the delivery triggermechanism of the wearable drug delivery device of FIG. 1.

FIG. 9A is a view of the wearable drug delivery device of FIG. 1 with anexample safety guard attached at the distal end of the device.

FIG. 9B is a view of the wearable drug delivery device of FIG. 1 withthe safety guard removed from the distal end of the device.

FIGS. 9C and 9D are views of a tear-away strip with a pull ring that canbe used with and removed from the wearable drug delivery device of FIG.1.

FIG. 10A is a view of the wearable drug delivery device of FIG. 1 beforeuse.

FIG. 10B is a view of the wearable drug delivery device of FIG. 1 afteruse.

FIGS. 10C-E are cut-away views of the wearable drug delivery of FIG. 1device with the trigger portion acting as a needle guard.

FIGS. 11A-C are views of example lockout features of the wearable drugdelivery device of FIG. 1 that inhibit the needle from being re-exposed.

FIGS. 12A and 12B are views of an example gate of the wearable drugdelivery device of FIG. 1.

FIG. 13 is a cut-away view of the wearable drug delivery device of FIG.1 with a mechanism for activating electronics.

FIG. 14 is block diagram of an example communication module of thewearable drug delivery device of FIG. 1.

FIGS. 15A-15C are views of an examples dose confirmation module of thewearable drug delivery device of FIG. 1.

FIG. 16 is perspective view of another embodiment of a wearable drugdelivery device, similar to but in some ways different than the deviceof FIG. 1.

FIG. 17 is a cut-away view of the wearable drug delivery device of FIG.16.

FIG. 18 is a close up view of an example integral drug delivery port ofthe wearable drug delivery device of FIG. 16.

FIGS. 19A and 19B are perspective views of an example needle assembly ofthe wearable drug delivery device of FIG. 16.

FIG. 19C is a cut-away view of the wearable drug delivery device of FIG.16 with the needle assembly in the extended position.

FIGS. 20A-D is a series of views of the drug delivery sequence of thewearable drug delivery device of FIG. 16.

FIGS. 21A and 21B are perspective views of an example trigger arm and anexample needle body of the wearable drug delivery device of FIG. 16.

FIGS. 21C-F is a series of views of a needle trigger mechanism sequenceof the wearable drug delivery device of FIG. 16.

FIGS. 22A and 22B are a series of views of a delivery trigger mechanismsequence of the wearable drug delivery device of FIG. 16.

FIGS. 23A and 23B are views of an example gate of the wearable drugdelivery device of FIG. 16.

FIG. 24A is a diagram of an example trigger guard of the wearable drugdelivery device of FIG. 16.

FIGS. 24B-E is a series of views showing the trigger guard being removedfrom the wearable drug delivery device of FIG. 16.

FIG. 25 is a cut-away view of the wearable drug delivery device of FIG.16 with a mechanism for activating electronics.

FIG. 26 is block diagram of an example communication module of thewearable drug delivery device of FIG. 16.

FIGS. 27A-27C are views of an example dose confirmation module of thewearable drug delivery device of FIG. 16.

DETAILED DESCRIPTION

The wearable drug delivery device provides a compact drug deliverymechanism that can be worn and can efficiently and/or rapidly deliver aprescribed drug dose. FIG. 1 shows an example of the wearable drugdelivery device 100 including a handheld portion 105 at a proximal end110 and a trigger portion 115 at a distal end 120. (Note: In the figure,the trigger portion 115 is hidden from view by a safety cover. Anexample of the trigger portion 115 is best seen in FIG. 9B with thesafety cover removed from view.) A longitudinal axis 125 extends betweenthe proximal end 110 and the distal end 120. The handheld portion 105can be constructed from a durable material, such as stainless steel,aluminum, polycarbonate, etc., to protect the internal components of thewearable drug delivery device 100 and/or the user of wearable drugdelivery device 100.

In the example shown in FIG. 1, the wearable drug delivery device 100further includes an adapter 130 for wearing the device on the uSer. Theadapter 130 extends from handheld portion 105 and terminates at asurface 135. The surface 135 is shaped to conform to the user's wrist,arm or other body part. For example, the surface 135 is concaved toengage to the rounded surface the user's wrist. The point of concavityof the surface 135 is defined by a point along an axis offset andparallel to longitudinal axis 125.

The adapter 130 can include a slot 140 for receiving a band (not shown),such as an arm or wrist band, for wearing the wearable drug deliverydevice 100. The wrist/arm band can be elastic or include a fastener,such as hook and loop, button or snap allowing the user to readilyremove the wearable drug delivery device 100 from their body when it'stime to use the device.

FIG. 2 shows the insides of the wearable drug delivery device 100. Thehandheld portion 105 is divided into two compartments that are arrangedside-by-side and aligned with the longitudinal axis 125. The firstcompartment 145 contains a needle assembly 150 and a penetrating spring155. As will be described in greater below, to pierce the user' skin thepenetrating spring 155 moves the needle assembly 150 within the firstcompartment 145 in the direction of the longitudinal axis 125 from aposition at the proximal end 110 to a position at the distal end 120.For ease of reference, the former position is called the “withdrawnposition” and the latter portion is called the “extended position”.Additionally, the proximal-to-distal direction is referred to as the“downward direction,” and the opposite direction is the “upwarddirection”.

The second compartment 160 contains a drug vial 165 surrounded in partby a rotator 170 and a piston 185. The piston 185, in turn, issurrounded by a vial spring 175. The concentric arrangement of theseparts is advantageous because it allows the wearable drug deliverydevice 100 to be short and wearable. As will be described in greaterdetail below, to inject the drug dose into the user, the vial spring 175moves the drug vial 165, the rotator 170, and the piston 185 downwardwithin the second compartment 160, and further moves a plunger 180downward within the drug vial 165. By way of non-limiting example, thedrug vial 165 can be filled with a dose of epinephrine or insulin.

The wearable drug delivery device 100 further includes at the distal end120, an integral drug delivery port 200 for providing a path for thedrug dose to flow from the drug vial 165 to the needle assembly 150. Inthe close up view of FIG. 3, the integral drug delivery port 200 extendstransversely between the first compartment 145 and the secondcompartment 160. The integral drug delivery port 200 includes a vialneedle 205 (entrance), an exit 210, and a channel 215 extending betweenthem.

When the drug vial 165 is moved in the downward direction, the vialneedle 205 encounters a vial membrane 220, which seals the drug vial165. As the drug vial 165 continues to move downward, the vial needle205 punctures the vial membrane 220. At this point, the drug vial 165 isin fluid communication with the integral drug delivery port 200. Thedrug dose flows out of the drug vial 165 through the vial needle 205 andthe channel 215, and then out the exit 210.

FIG. 4A shows an example of the needle assembly 150, including a needlebody 300, a needle 310, and a tip 315. The needle body 300 is the basethe needle assembly 150 and includes a needle port 320. The needle 310extends from the needle body 300 and terminates at the tip 315. As bestseen in FIG. 4B, the needle 310 has the approximate shape of the letter“J” with a central lumen 325 extending from the tip 315 at one end tothe needle port 320 at the other. Fluid entering the needle port 320flows through the central lumen 325 and out of the tip 315.

FIG. 4C shows the needle assembly 150 in the extended position within areceiving portion 330 of the handheld portion 105. As shown, thereceiving portion 330 has a shape complementary to the shape of theneedle body 300. The receiving portion 330 includes an upper part, alower part, and a shoulder connecting them. The upper part correspondswith the needle assembly needle body 300 and includes the exit 210 ofthe integral drug delivery port 200.

With the needle assembly 150 in the extended position, the exit 210 ofthe integral drug delivery port 200 and needle port 320 are in fluidcommunication with each other. In some examples, the exit 210 is aseptum seal that is pierced by the needle port 320 when the needleassembly 150 is in the extended position. This is beneficial because thechannel 215 is sealed until the needle assembly 150 is positionedcorrectly. Fluid flows from the drug vial 165 through the integral drugdelivery port 200 and the needle port 320, and out of the needle 310.This arrangement is advantageous because it does not require a directconnection between the needle assembly 150 and the drug vial 165. Insome examples, the receiving portion 330 may be made leak resistant by adownward force applied from the penetration spring 155.

FIGS. 5A-B shows an example sequence of orchestrated events startingwith a user triggering the wearable drug delivery device 100 and endingwith a drug dose delivered to the uSer. Starting in FIG. 5A, the usertriggers the wearable drug delivery device 100 by depressing the triggerportion 115 against their thigh, for example. This simultaneouslyactuates a needle trigger mechanism and a delivery trigger mechanism(both of which are described in greater detail below). The concurrentactivation, in turn, releases energy stored in the penetration spring155 and the vial spring 175.

In FIG. 5B, the penetration spring 155 drives the needle assembly 150downwards within the first compartment 145 from the withdrawn positionto the extended position. In the extended position, the needle 310projects beyond the distal end 120 of the wearable drug delivery device100 and into the user's thigh. Contemporaneous with the needledeployment, the vial spring 175 drives the drug vial 165, the rotator170, and the piston 185 downward toward the vial needle 205.

In FIG. 5C, the drug vial 165, the rotator 170, and the piston 185continue moving downward until the vial needle 205 punctures the vialmembrane 220. The drug vial 165 continues to move downward until a stop225 extending up from the distal end 120 prevents the drug vial 165 frommoving further downward. At this point, the drug vial 165 is fullyseated in its final position (i.e., the seated position). The vialspring 175, however, is not yet fully extended and still has more travelleft.

Continuing in FIG. 5C, as the vial spring 175 continues to push thepiston 185 downward, the piston 185 drives the plunger 180 downwardwithin the seated drug vial 165 expelling the drug dose from the drugvial 165. The expelled drug dose flows through the integral drugdelivery port 200 and needle assembly 150, out the needle 310, and intothe user's thigh.

Turning now to a detailed discussion of the needle trigger mechanism,the mechanism operates via the trigger portion 115, which contacts theuser's target injection area (e.g., thigh). The trigger portion 115includes two trigger arms one that extend into the handheld portion 105,one of which is shown in FIGS. 6A and 6B. When the user pushes down onthe trigger portion 115, the trigger arms 400 move upward within thehandheld portion 105.

As more clearly seen in FIGS. 6B and 6C with the handheld portionremoved from view, each of the trigger arms 400 has a support pad 405that normally supports the spring loaded needle assembly 150. The needlebody 300 includes ears 305 each normally supported by a trigger armsupport pad 405. The example needle body 300 shown in FIG. 6C includesthe ears 305 spaced 180° apart, which corresponds to a similararrangement of the trigger arms 400.

The support pads 405 and ears 305 can each have an angled surface thatfacilitates cooperation between the needle body 300 and the trigger arms400. As the trigger arms 400 are moved upward by the trigger portion115, the angled surfaces cause the needle body 300 to lift and rotateaway from the trigger arm support pads 405, as seen in FIG. 6D (showingone of the trigger arms 400). Once the trigger arm support pads 405reach a trigger point, as seen in FIG. 6E (showing one of the triggerarms 400), the needle body 300 can rotate underneath the trigger armsupport pads 405, as seen in FIG. 6F (showing one of the trigger arms400). No longer supported, the needle assembly 150 can then travelfreely downward towards the target injection site (denoted by thearrow), as seen in FIG. 6G (showing one of the trigger arms 400).

Turning now to a detailed discussion of the delivery trigger mechanism,like the needle trigger mechanism described above, the mechanism alsooperates via the trigger portion 115. FIG. 7A shows the rotator 170including a trio of legs 190 (there can be fewer legs, e.g., two or morelegs, e.g., four). The legs 190 rest on a trio of corresponding yokes500 extending from the distal end of the second compartment 160 shown inFIG. 7B. The yokes 500 resist downward movement of the rotator 170caused by the vial spring 175 (of FIG. 2). The yokes 500 have shapedsurfaces 505 corresponding to the shape of the legs 190 to furtherinhibit downward movement. Each of the yokes 500 has a passageway 510extending between the inside and outside of the second compartment 160.

FIG. 7C shows a trio of angled trigger blades 520 extending from thedistal end of the trigger portion 115. Each of the blades 520 has angledsurface 525 at its end that encourages the rotator 170 to turn in asingle direction. When the trigger portion 115 is depressed against theuser's thigh, for example, the angled trigger blades 520 slide throughthe passageways 510 with the angled surfaces 525 extending beyond theshaped surfaces 505.

The operation of the delivery trigger mechanism is now described withreference to FIGS. 8A-8D showing one of the rotator legs 190, one of theyokes 500, and one of the angled trigger blades 520. Before activatingthe mechanism, the rotator legs 190 are pushed down into the yokes 500(shown as an arrow pointing to the bottom of the figure) by the vialspring 175 (of FIG. 2). The shaped surfaces 505 further hold the legs190 in place. The angled trigger blades 520 sit below the shapedsurfaces 505 within the passageways 510 and do not contact the legs 190.

Shown in FIG. 8B, when the trigger portion 115 moves towards thehandheld portion 105, the angled trigger blades 520 slide upward withinthe passageways 510 and contact the rotator legs 190. Due to the inclineof the angled surfaces 525, the angled trigger blades 520 initially liftthe legs 190 off of the yokes 500. The incline of the angled surfaces525 together with downward force from the vial spring 175 (of FIG. 2)cause the legs 190 to then slide along the surfaces 525 turning therotator 170 in the process (not shown).

Shown in FIG. 8C, the rotator 170 slides off of the angled triggerblades 520 (shown as an arrow pointing to the left of the figure) andwhile being pushed downward (shown as an arrow pointing to the bottom ofthe figure). FIG. 8D shows the rotator 170 shown fully rotated off theyokes 500 and in final position.

FIG. 9A shows an safety guard 700 attached to the handheld portion 105covering the trigger portion (hidden from view). The safety guard 700prevents the wearable drug delivery device 100 from being triggered,inadvertently. The safety guard 700 can also act as a sterile barrierand/or a barrier to dirt and water intrusion. The safety guard 700 canbe attached to the handheld portion 105 by way of a frangible weld jointformed by a process, such as such as laser welding or ultrasonicwelding. The safety guard 700 can also be attached to the handheldportion 105 by friction or interference fit.

The safety guard 700 can be removable by simple force or by using atearaway strip 705 as shown in the figure. In the example shown, thetear-away strip 705 is disposed circumferentially between the handheldportion 105 and the safety guard 700. In use, the user pulls on thetear-away strip 705 to remove the tear-away strip 705 from the wearabledrug delivery device 100. This separates the safety guard 700 from thehandheld portion 105. The user action can be facilitated by one or morepre-weakened areas (not shown) in the tear-away strip 705. For example,material joining the tear-away strip 705 to the handheld portion 105 andthe safety guard 700 can be thinned making it easier to remove thetear-away strip 705 away from the wearable drug delivery device 100. Inanother example, material joining the tear-away strip 705 to thehandheld portion 105 and the safety guard 700 can be perforated, makingit easier to peel the tear-away strip 705 away from the wearable drugdelivery device 100. FIG. 9B shows the wearable drug delivery device 100ready for use with safety guard removed and the trigger portion 115exposed.

FIG. 9C shows a pull ring 710 extending from a point along the tear-awaystrip 705. The pull ring 710 facilitates removing the tear-away strip705 from the wearable drug delivery device 100 to allow the device 100to be triggered. The pull ring 710 can swing towards or away from thetear-away strip 705 by way of a virtual hinge 715. The virtual hinge 715is located at the base of the pull ring 710 where it extends from thetear-away strip 705.

When the user wears the wearable drug delivery device 100 around theirwrist (or other body part), the pull ring 710 swings towards thewearable drug delivery device 100, and is sandwiched between thewearable drug delivery device 100 and the user's wrist (or other bodypart). In this position, the user cannot access or otherwise use thepull ring 710 to remove the tear-away strip 705 and thus, cannot triggerthe wearable drug delivery device.

As shown in FIG. 9D, when the user removes the wearable drug deliverydevice 100 from their wrist (or other body part), the pull ring 710swings away from the wearable drug delivery device. In this deployedposition, the user can access the pull ring 710 and pull on it to removethe tear-away strip 705 from the wearable drug delivery device 100; andthus can trigger the device 100. This feature is useful because thewearable drug delivery device cannot be activated while wearing thedevice. The wearable drug delivery device can only be activated when thedevice is removed from the user's wrist (or other body part), thusadding to the safety of the device.

The trigger portion 115 can also act as a needle guard/sharps protectorafter the wearable drug delivery device 100 is used. FIG. 10A shows thearrangement of the wearable drug delivery device 100 before it is usedwith the trigger portion 115 proximal (close) to the handheld portion105. FIG. 10B shows the arrangement of the wearable drug delivery device100 after it is used with the trigger portion 115 distal (far) from thehandheld portion 105.

FIG. 10C shows a cross-section of the before use arrangement of thewearable drug delivery device 100 shown in FIG. 10A. A leaf spring 800prevents the trigger portion 115 from advancing away from the handheldportion 105. The leaf spring 800 has a fixed end 805 attached to thetrigger portion 115. As best seen in FIG. 10D, the leaf spring 800further has a free end 810 opposite the fixed end 805.

During assembly of the wearable drug delivery device 100, the leafspring 800 is bent into the configuration shown and the free end 810engages one or more hooks 815 on the handheld portion 105. A returnspring 820 sandwiched between the handheld portion 105 and triggerportion 115 supplies a force urging (separating) the handheld portion105 and the trigger portion 115 apart. This force enhances the latchingof the leaf spring 800 and inhibits the leaf spring 800 from becomingaccidently disengaged from the hooks 815.

FIG. 10D shows during the use of the wearable drug delivery device 100,when the trigger portion 115 is pushed down (i.e., brought towards thehandheld portion 105) the leaf spring 800 moves upward relative to thehandheld portion 105 and the free end 810 disengages from the hooks 815.The leaf spring 800 returns back to its natural shape as shown. With thetrigger portion 115 in this position, the needle 310 is exposed andextends beyond the trigger portion 115.

FIG. 10E shows a cross-section of the after use arrangement of thewearable drug delivery device 100 shown in FIG. 10B. When the userremoves the downward force from the device 100, the return spring 820moves the trigger portion 115 away from the handheld portion 105. Inthis position, referred to as the “guard position” for ease ofreference, the trigger portion 115 covers the needle 310. The triggerportion 115 can be maintained in the guard position using one or more of“lock-out” features described immediately below.

FIG. 11A shows one-way barbs 825 projecting from an exterior surface 830of the handheld portion 105. The trigger portion 115 includes snapfeatures 835. The snap features 835 are joined to the trigger portion115 by virtual hinges 840. While the trigger portion 115 advancesdownward away from the handheld portion 105, the snap features 835 rideover the one-way barbs 825 and flex about the virtual hinges 840 awayfrom the exterior surface 830. The one-way barbs 825 and snap features835 prevent the trigger portion 115 from moving back towards thehandheld portion 105 and re-exposing the needle.

FIG. 11B shows the trigger portion 115 with one-way teeth 845 (oneshown) that ride in slots 850 (one shown) in the handheld portion 105.The shapes of the one-way teeth 845 and the slots 850 inhibit thetrigger portion 115 from coming off the handheld portion 105 (i.e.,being disassembled) and re-exposing the needle. At the same time, theshapes allow the wearable drug delivery device 100 to be readilyassembled from the handheld portion 105 and trigger portion 115.

FIG. 11C shows a return spring 855 being a torsion spring. When thereturn spring 855 is in the opened position as shown, the return spring855 inhibits the trigger portion 115 from moving back towards thehandheld portion 105 and re-exposing the needle 310.

FIG. 12A shows an example gate 600 for enabling the drug to flow fromthe drug vial 165 to the needle assembly 150 (representeddiagrammatically in the figure as circles for clarity). The gate 600includes a planar member 605 extending from the trigger portion 115towards the handheld portion (not shown in the figure for clarity). Theplanar member 605 divides the channel into an upper channel portion 215a and a lower channel portion 215 b.

The gate 600 further includes an opening 610 through the planer member605. The planar member 605 moves in the direction of the longitudinalaxis 125 in between the upper and lower channel portions 215 a and 215 bconsistent with the movement of the trigger portion 115. When thetrigger portion 115 is not depressed or partly depressed, the opening610 is not aligned with the upper and lower channel portions 215 a and215 b, as shown in the figure, and the planer member 605 obstructs thechannel With the gate 600 in this “closed” position, the drug cannotflow between the drug vial 165 and the needle assembly 150.

In FIG. 12B, when the user triggers the wearable drug delivery deviceand fully depresses the triggerportion 115, the gate 600 moves upwardtowards the handheld portion and the opening 610 is aligned with theupper and lower channel portions 215 a and 215 b as shown. With the gate600 in this “open” position the upper and lower channel portions 215 aand 215 b are in fluid communication and the channel is generallyunobstructed. This allows the drug to flow from the drug vial 165 to theneedle assembly 150. The gate 600 is particularly advantage because thesingle act of triggering the wearable drug delivery device has the addedfunction of enabling drug flow.

FIG. 13 shows another example of the safety guard 700 including a tooth720 for controlling electronics 860, such as a communication module,housed within the handheld portion 105. The tooth 720 extends from aninterior surface 725 of the safety guard 700. When the safety guard 700is on the wearable drug delivery device 100, the tooth 720 extends intothe handheld portion 105 through a slot. Inside, the tooth 720 ispositioned between an electrical contact 865 and a battery 870. Theelectrical contact 865 and battery 870 are electrically coupled to theelectronics 860 to form an electronic circuit 875.

The tooth 720 is made from nonconductive material, such as plastic.(Some examples of the safety guard 700 are made from one material, inwhich case, the safety guard 700 is nonconductive). Consequently,positioning the tooth 720 between the electrical contact 865 and battery870 creates a discontinuity in the electronic circuit 875 and theelectronics 860 is inactive. The tooth feature is also advantageousbecause it reduces the loss of battery power over time, which in turnincreases the shelf life of the wearable drug delivery device 100.

When the safety guard 700 is removed from the wearable drug deliverydevice 100 (e.g., to activate the wearable drug delivery device 100),the tooth 720 is pulled out the handheld portion 105 allowing theelectrical contact 865 and the battery 870 to connect. This completesthe electrical circuit 875 and activates the electronics 860. Thisarrangement is particularly advantageous because both the wearable drugdelivery device 100 and the electronics 860 can be activated at the sametime with one action. Additional, no additional electronic componentlike a switch is required to control the electronics 860, making theelectronic circuit 875 simpler, less costly, and more reliable.

As just described, the electronics 860 can be a communication module.The communication module can provide information to the user when theyactivate the wearable drug delivery device (e.g., when they remove thesafety guard 700). For example, speakers built into the wearable drugdelivery device 100 play an audio recording of how to use the devicewhen the user activates the device. It is understood that is beneficialto provide instructions to the user as the user is carrying them out.

In FIG. 14, another example of the communication module 900 can provideinformation to a healthcare provider 905, wirelessly, using cellular,WI-FI, BLUETOOTH, Z-WAVE, and ZIGBEE—just to name a few wirelesscommunication protocols. In examples using short range wireless, such asthe CC2640 SIMPLELINK BLUETOOTH Wireless Micro Controller Unit by TEXASINSTRUMENTS, the communication module 900 can be wirelessly coupled(networked) to a user device 910, such as a smartphone. The user device910, in turn, connects to a healthcare provider 905 and relays theinformation. This can be accomplished using an application running onthe user device 910. Advantageously, the healthcare provider 905 isnotified whenever the user activates the wearable drug delivery device,thus adding safety to the device.

A challenge to using an autoinjector to self-administer a drug dose ismaking sure that the autoinjector needle penetrates the body to a properdepth for delivering the drug. Delivering the drug dose too shallow inthe body can reduce the effectiveness of the drug dose or worst yet not,the drug dose has no effect. The present invention addresses thischallenge with a dose confirmation module for determining whether aneedle has reached a proper depth based on impedance. Impedance changesthe deeper the needle goes into conductive tissue, such as skin, fat,and muscle. This is because increased contact with the conductivematerial changes the overall impedance. The dose confirmation modulethen notifies a user or healthcare provider whether the proper depth hasbeen reached.

In FIG. 15A, wearable drug delivery device 100 includes a doseconfirmation module 1000 electrically coupled to needle 1005 (shown inthe extended position) and a conductor 1010. With the needle 1005 andconductor 1010 in air, as shown in the figure, the dose confirmationmodule 1000 measures an impedance of >1,000 ohm (open circuit). In FIG.15B, the needle 1005 is inserted into muscle (a conductive medium) andthe conductor 1010 is in contact with the skin overlaying the muscle(another conductive medium) the measured impedance is about 83 ohms.

FIG. 15C shows an alternative to the needle 1005 and conductor 1010configuration of FIG. 15A. The alternative configuration includes acombination needle 1020 having a positive distal region 1025 isolatedfrom a negative proximal region 1030 by an insulating bushing 1035. (Thepolarities of the distal and proximal regions can be switched.) Thecombination needle 1020 is electrically coupled to the dose confirmationmodule 1000. With the combination needle 1020 in air, the doseconfirmation module 1000 measures an impedance of >1,000 ohm (opencircuit). When the combination needle 1020 penetrates the skin andunderlying muscle, both the positive distal region 1025 and the negativeproximal region 1030 are in conductive medium; and the dose confirmationmodule 1000 measures impedance less than 1,000 ohm.

The dose confirmation module 1000 compares the measured impedance to athreshold value and based on the comparison, confirms whether the needle1005 or combination needle 1020 has reached a proper depth fordelivering the drug dose. For example, if the measured impedance is lessthan or equal to 83 ohms, the dose confirmation module 1000 determinesthat the proper depth for the injection has been reached (i.e., OK).Impedance measurements greater than 83 ohms indicate that the properdepth for the injection has not been reached (i.e., NOT OK).

A dose confirmation can be communicated to the user using an audio cue(e.g., one beep for OK or two beeps for NOT OK) or a visual cue (e.g., alit green light for OK or a lit red light for NOT OK). The doseconfirmation can also be communicated to a healthcare provider using thecommunication module 900 described above with reference to FIG. 14.Advantageously, the foregoing examples can provide the user withimmediate feedback on whether they used the wearable drug deliverydevice 100 correctly and/or notify a healthcare provider of the same. Insome cases, the user and/or healthcare can take corrective measure basedon the information.

FIG. 16 shows another exemplary wearable drug delivery device 2100including a handheld portion 2105 at a proximal end 2110 and a triggerportion 2115 at a distal end 2120. A longitudinal axis 2125 extendsbetween the proximal end 2110 and the distal end 2120. The handheldportion 2105 can be constructed of a durable material, such as stainlesssteel, aluminum, polycarbonate, etc., to protect the internal componentsof the wearable drug delivery device 2100 and/or the user of wearabledrug delivery device 2100.

In the example shown in FIG. 16, the wearable drug delivery device 2100further includes an adapter 2130 for wearing the device on the uSer. Theadapter 2130 extends from handheld portion 2105 and terminates at asurface 2135. The surface 2135 is shaped to conform to the user's wrist,arm or other body part. For example, the surface 2135 is concaved toengage to the rounded surface the user's wrist. The point of concavityof the surface 2135 is defined by a point along an axis offset andparallel to longitudinal axis 2125.

The adapter 2130 can include a slot 2140 for receiving a band (notshown), such as an arm or wrist band, for wearing the wearable drugdelivery device 2100. The wrist/arm band can be elastic or include afastener, such as hook and loop, button or snap allowing the user toreadily remove the wearable drug delivery device 2100 from their bodywhen it's time to use the device.

FIG. 17 shows the insides of the wearable drug delivery device 2100. Thehandheld portion 2105 is divided into two compartments that are arrangedside-by-side and aligned with the longitudinal axis 2125. The firstcompartment 2145 contains a needle assembly 2150 and a penetratingspring 2155. As will be described in greater below, to pierce the user'skin the penetrating spring 2155 moves the needle assembly 2150 withinthe first compartment 2145 in the direction of the longitudinal axis2125 from a position at the proximal end 2110 to a position at thedistal end 2120. For ease of reference, the former position is calledthe “withdrawn position” and the latter portion is called the “extendedposition”. Additionally, the proximal-to-distal direction is referred toas the “downward direction,” and the opposite direction is the “upwarddirection”.

The second compartment 2160 contains a drug vial 2165 surrounded by arotator 2170, all of which are surrounded by a vial spring 2175. Theconcentric arrangement of these parts is advantageous because it allowsthe wearable drug delivery device 2100 to be short and wearable. As willbe described in greater detail below, to inject the drug dose into theuser, the vial spring 2175 moves the drug vial 2165 and the rotator 2170downward within the second compartment 2160, and further moves a plunger2180 downward within the drug vial 2165. By way of non-limiting example,the drug vial 2165 can be filled with a dose of epinephrine or insulin.

The wearable drug delivery device 2100 further includes at the distalend 2120, an integral drug delivery port 2200 for providing a path forthe drug dose to flow from the drug vial 2165 to the needle assembly2150. In the close up view of FIG. 18, the integral drug delivery port2200 extends transversely between the first compartment 2145 and thesecond compartment 2160. The integral drug delivery port 2200 includes avial needle 2205 (entrance), an exit 2210, and a channel 2215 extendingbetween them.

When the drug vial 2165 is moved in the downward direction, the vialneedle 2205 encounters a vial membrane 2220, which seals the drug vial2165. As the drug vial 2165 continues to move downward, the vial needle2205 punctures the vial membrane 2220. At this point, the drug vial 2165is in fluid communication with the integral drug delivery port 2200. Thedrug dose flows out of the drug vial 2165 through the vial needle 2205and the channel 2215, and then out the exit 2210. The vial needle 2205can be located above the exit 2210 to help fluid flow out of the drugvial 2165.

FIG. 19A shows an example of the needle assembly 2150, including aneedle body 2300, a needle 2310, and a tip 2315. The needle body 2300forms the base of the needle assembly 2150 and includes a needle port2320. The needle 2310 extends from the needle body 2300 and terminatesat the tip 2315. As best seen in FIG. 19B, the needle 2310 includes acentral lumen 2325 extending from the tip 2315 at one end. The needleport 2320 extends radially from the other end of the central lumen 2325.Fluid entering the needle port 2320 flows through the central lumen 2325and out of the tip 2315.

FIG. 19C shows the needle assembly 2150 in the extended position withina receiving portion 2330 of the handheld portion 2105. As shown, thereceiving portion 2330 has a shape complementary to the shape of theneedle body 2300. The receiving portion 2330 includes an upper part, alower part, and a shoulder connecting them. The upper part correspondswith the needle assembly needle body 2300 and includes the exit 2210 ofthe integral drug delivery port 2200.

With the needle assembly 2150 in the extended position, the exit 2210 ofthe integral drug delivery port 2200 and needle port 2320 are in fluidcommunication with each other. Fluid flows from the drug vial 2165through the integral drug delivery port 2200 and the needle port 2320,and out of the needle 2310. In the examples shown, the needle assembly2150 includes seals 2335 a and 2335 b above and below the needle port2320. In the extended position, the seals 2335 a and 2335 b close offthe upper part of the receiving portion 2330 allowing fluid entering theupper part from the exit 2210 to flow into the needle port 2320. Thisarrangement is advantageous because it does not require a directconnection between the needle assembly 2150 and the drug vial 2165. Insome examples, the upper part may be further made leak resistant by adownward force applied from the penetration spring 2155.

FIGS. 20A-B shows an example sequence of orchestrated events startingwith a user triggering the wearable drug delivery device 2100 and endingwith a drug dose delivered to the uSer. Starting in FIG. 20A, the usertriggers the wearable drug delivery device 2100 by depressing thetrigger portion 2115 against their thigh, for example. This actuates aneedle trigger mechanism (described in greater detail below), which inturn releases energy stored in the penetration spring 2155.

In FIG. 20B, the penetration spring 2155 drives the needle assembly 2150downwards within the first compartment 2145 from the withdrawn positionto the extended position. In the extended position, the needle 2310projects beyond the distal end 2120 of the wearable drug delivery device2100 and into the user's thigh. Moving the needle assembly 2150 downwardto the extended position activates a delivery trigger mechanism(described below in greater detail). This in turn releases energy storedin the vial spring 2175. As the vial spring 2175 expands, it drives therotator and drug vial 2165 downward where the vial needle 2205 meets thevial membrane 2220.

In FIG. 20C, the rotator 2170 and the drug vial 2165 continue movingdownward until the vial needle 2205 punctures the vial membrane 2220.The drug vial 2165 continues to move downward until a stop 2225extending up from the distal end 2120 prevents the drug vial 2165 frommoving further downward. At this point, the vial spring 2175 is not yetfully extended and still has more travel left.

In FIG. 20D, the rotator 2170 includes a piston 2185 at one end thatabuts the plunger 2180 within the drug vial 2165. As the vial spring2175 continues to push the rotator 2170 downward, the piston 2185 drivesthe plunger 2180 downward within the drug vial 2165 expelling the drugdose from the drug vial 2165. The expelled drug dose flows through theintegral drug delivery port 2200 and needle assembly 2150, out theneedle 2310, and into the user's thigh.

Turning now to detailed discussion of the needle trigger mechanism, themechanism operates via the trigger portion 2115, which contacts theuser's target injection area (e.g., thigh). The trigger portion 2115includes one or more trigger arms 2400 (e.g., two trigger arms) shown inFIG. 21A that extend into the handheld portion 2105. When the userpushes down on the trigger portion 2115, the trigger arm 2400 movesupward within the handheld portion 2105.

A support pad 2405 on the trigger arm 2400 normally supports the springloaded needle assembly 2150. The needle body 2300 includes one or moreears 2305 each normally supported by a trigger arm support pad. Theexample needle body 2300 shown in FIG. 21B includes two ears 2305 a and2305 b spaced 180° apart, which corresponds to a similar arrangementtrigger arms. The needle body 2300 further includes an arm 2340, whichis used for the delivery trigger mechanism described below.

The support pad 2405 and ear 2305 can each have an angled surface thatfacilitates cooperation between the needle body 2300 and the trigger arm2400. As the trigger arm 2400 is moved upward by the trigger portion2115, the angled surfaces cause the needle body 2300 to lift and rotateaway from the trigger arm support pad 2405, as seen in FIG. 21C. Oncethe trigger arm support pad 2405 reaches a trigger point, as seen inFIG. 21D, the needle body 2300 can rotate underneath the trigger armsupport pad 2405, as seen in FIG. 21E. No longer supported, the needleassembly 2150 can then travel freely downward towards the targetinjection site, as seen in FIG. 21F.

FIGS. 22A and 22B show an example of the delivery trigger mechanismmentioned above. The rotator 2170 includes a pair of legs 2190 at theend opposite the piston 2185. The legs 2190 rest on a pair ofcorresponding yokes 2500 extending from the distal end of the handheldportion 2105. The yokes 2500 resist downward movement by the rotator2170 but their shape encourages the rotator 2170 to turn. As shown inFIG. 22A, a latch 2505 in cooperation with a pin 2195 projecting fromthe one of the legs 2190 resists this rotational movement.

In FIG. 22B, as the needle assembly 2150 reaches the extended position;the arm 2340 projecting from then needle assembly 2150 pushes the latch2505 downward. With the latch 2505 down and the pin 2195 free, therotator 2170 revolves off of the yokes 2500 (represented in the figureas a curved arrow), enabling the vial spring 2175 to drive the rotator2170 and drug vial 2165 downward as described above.

FIG. 23A shows an example gate 2600 for enabling the drug to flow fromthe drug vial 2165 to the needle assembly 2150 (representeddiagrammatically in the figure as circles for clarity). The gate 2600includes a planar member 2605 extending from the trigger portion 2115towards the handheld portion (not shown in the figure for clarity). Theplanar member 2605 divides the channel into an upper channel portion2215 a and a lower channel portion 2215 b.

The gate 2600 further includes an opening 2610 through the planer member2605. The planar member 2605 moves in the direction of the longitudinalaxis 2125 in between the upper and lower channel portions 2215 a and2215 b consistent with the movement of the trigger portion 2115. Whenthe trigger portion 2115 is not depressed or partly depressed, theopening 2610 is not aligned with the upper and lower channel portions2215 a and 2215 b, as shown in the figure, and the planer member 2605obstructs the channel With the gate 2600 in this “closed” position, thedrug cannot flow between the drug vial 2165 and the needle assembly2150.

In FIG. 23B, when the user triggers the wearable drug delivery deviceand fully depresses the trigger portion 2115, the gate 2600 moves upwardtowards the handheld portion and the opening 2610 is aligned with theupper and lower channel portions 2215 a and 2215 b as shown. With thegate 2600 in this “open” position the upper and lower channel portions2215 a and 2215 b are in fluid communication and the channel isgenerally unobstructed. This allows the drug to flow from the drug vial2165 to the needle assembly 2150. The gate 2600 is particularlyadvantage because the single act of triggering the wearable drugdelivery device has the added function of enabling drug flow.

FIG. 24A shows an example trigger guard 2700 for preventing the wearabledrug delivery device from being triggered, inadvertently. The triggerguard 2700 includes a separation strip 2705 that fits in a gap betweenthe handheld portion 2105 and the trigger portion 2115, as shown in FIG.24B. When the trigger portion 2115 is depressed, the separation strip2705 keeps the handheld portion 2105 and the trigger portion 2115 fromcoming together and the wearable drug delivery device cannot betriggered.

Referring back to FIG. 23A, the trigger guard 2700 further includes apull ring 2710 extending from a point along the separation strip 2705.The pull ring 2710 facilitates removing the separation strip 2705 fromthe gap to allow the wearable drug delivery device 2100 to be triggered.The pull ring 2710 can swing towards or away from the separation strip2705 by way of a virtual hinge 2715. The virtual hinge 2715 is locatedat the base of the pull ring 2710 where it extends from the separationstrip 2705.

When the user wears the wearable drug delivery device 2100 around theirwrist (or other body part), the pull ring 2710 swings towards thewearable drug delivery device 2100, and is sandwiched between thewearable drug delivery device 2100 and the user's wrist (or other bodypart). In this position, the user cannot access or otherwise use thepull ring 2710 to remove the separation strip 2705 and thus, cannottrigger the wearable drug delivery device.

As shown in FIG. 24C, when the user removes the wearable drug deliverydevice 2100 from their wrist (or other body part), the pull ring 2710swings away from the wearable drug delivery device. In this deployedposition, the user can access the pull ring 2710 and pull on it toremove the separation strip 2705 from the wearable drug delivery device;and thus can trigger the device. This feature is useful because thewearable drug delivery device cannot be activated while wearing thedevice. The wearable drug delivery device can only be activated when thedevice is removed from the user's wrist (or other body part), thusadding to the safety of the device.

As shown in FIGS. 24D and 24E, the user unwraps the separation strip2705 from the wearable drug delivery device uses the pull ring 2710.This user action can be further facilitated by one or more pre-weakenedareas (not shown) in the separation strip 2705. For example, materialjoining the separation strip 2705 to the handheld portion 2105 and thetrigger portion 2115 can be thinned making it easier to tear theseparation strip 2705 away from the wearable drug delivery device. Inanother example, material joining the separation strip 2705 to thehandheld portion 2105 and the trigger portion 2115 can be perforated,making it easier to tear the separation strip 2705 away from thewearable drug delivery device.

FIG. 25 shows another example of the trigger guard 2700 including atooth 2720 for controlling electronics 2800, such as a communicationmodule, housed within the handheld portion 2105. The tooth 2720 extendsfrom the separation strip 2705 in the direction of the short dimensionof the trigger guard 2700. When the trigger guard 2700 is on thewearable drug delivery device 2100, the tooth 2720 extends into thehandheld portion 2105 through a slot. Inside, the tooth 2720 ispositioned between an electrical contact 2805 and a battery 2810. Theelectrical contact 2805 and battery 2810 are electrically coupled to theelectronics 2800 to form an electronic circuit 2815.

The tooth 2720 is made from nonconductive material, such as plastic.(Some examples of the trigger guard 2700 are made from one material, inwhich case, the entire trigger guard 2700 is nonconductive).Consequently, positioning the tooth 2720 between the electrical contact2805 and battery 2810 creates a discontinuity in the electronic circuit2815 and the electronics 2800 is inactive. The tooth feature is alsoadvantageous because it reduces the loss of battery power over time,which in turn increases the shelf life of the wearable drug deliverydevice 2100.

When the trigger guard 2700 is removed from the wearable drug deliverydevice 2100 (e.g., to activate the wearable drug delivery device 2100),the tooth 2720 is pulled out the handheld portion 2105 allowing theelectrical contact 2805 and the battery 2810 to connect. This completesthe electrical circuit 2815 and activates the electronics 2800. Thisarrangement is particularly advantageous because both the wearable drugdelivery device 2100 and the electronics 2800 can be activated at thesame time with one action. Additional, no additional electroniccomponent like a switch is required to control the electronics 2800,making the electronic circuit 2815 simpler, less costly, and morereliable.

As just described, the electronics 2800 can be a communication module.The communication module can provide information to the user when theyactivate the wearable drug delivery device (e.g., when they remove thetrigger guard 2700). For example, speakers built into the wearable drugdelivery device 2100 play an audio recording of how to use the devicewhen the user activates the device. It is understood that is beneficialto provide instructions to the user as the user is carrying them out.

In FIG. 26, another example of the communication module 2900 can provideinformation to a healthcare provider 2905, wirelessly, using cellular,WI-FI, BLUETOOTH, Z-WAVE, and ZIGBEE—just to name a few wirelesscommunication protocols. In examples using short range wireless, such asthe CC2640 SIMPLELINK BLUETOOTH Wireless Micro Controller Unit by TEXASINSTRUMENTS, the communication module 2900 can be wirelessly coupled(networked) to a user device 2910, such as a smartphone. The user device2910, in turn, connects to a healthcare provider 2905 and relays theinformation. This can be accomplished using an application running onthe user device 2910. Advantageously, the healthcare provider 2905 isnotified whenever the user activates the wearable drug delivery device,thus adding safety to the device.

A challenge to using an autoinjector to self-administer a drug dose ismaking sure that the autoinjector needle penetrates the body to a properdepth for delivering the drug. Delivering the drug dose too shallow inthe body can reduce the effectiveness of the drug dose or worst yet not,the drug dose has no effect. The present invention addresses thischallenge with a dose confirmation module for determining whether aneedle has reached a proper depth based on impedance. Impedance changesthe deeper the needle goes into conductive tissue, such as skin, fat,and muscle. This is because increased contact with the conductivematerial changes the overall impedance. The dose confirmation modulethen notifies a user or healthcare provider whether the proper depth hasbeen reached.

In FIG. 27A, wearable drug delivery device 2100 includes a doseconfirmation module 21000 electrically coupled to needle 21005 (shown inthe extended position) and a conductor 21010. With the needle 21005 andconductor 21010 in air, as shown in the figure, the dose confirmationmodule 21000 measures an impedance of >1,000 ohm (open circuit). In FIG.27B, the needle 21005 is inserted into muscle (a conductive medium) andthe conductor 21010 is in contact with the skin overlaying the muscle(another conductive medium) the measured impedance is about 83 ohms.

FIG. 27C shows an alternative to the needle 21005 and conductor 21010configuration of FIG. 27A. The alternative configuration includes acombination needle 21020 having a positive distal region 21025 isolatedfrom a negative proximal region 21030 by an insulating bushing 21035.(The polarities of the distal and proximal regions can be switched.) Thecombination needle 21020 is electrically coupled to the doseconfirmation module 21000. With the combination needle 21020 in air, thedose confirmation module 21000 measures an impedance of >1,000 ohm (opencircuit). When the combination needle 21020 penetrates the skin andunderlying muscle, both the positive distal region 21025 and thenegative proximal region 21030 are in conductive medium; and the doseconfirmation module 21000 measures impedance less than 1,000 ohm.

The dose confirmation module 21000 compares the measured impedance to athreshold value and based on the comparison, confirms whether the needle21005 or combination needle 21020 has reached a proper depth fordelivering the drug dose. For example, if the measured impedance is lessthan or equal to 83 ohms, the dose confirmation module 21000 determinesthat the proper depth for the injection has been reached (i.e., OK).Impedance measurements greater than 83 ohms indicate that the properdepth for the injection has not been reached (i.e., NOT OK).

A dose confirmation can be communicated to the user using an audio cue(e.g., one beep for OK or two beeps for NOT OK) or a visual cue (e.g., alit green light for OK or a lit red light for NOT OK). The doseconfirmation can also be communicated to a healthcare provider using thecommunication module 2900 described above with reference to FIG. 26.Advantageously, the foregoing examples can provide the user withimmediate feedback on whether they used the wearable drug deliverydevice 2100 correctly and/or notify a healthcare provider of the same.In some cases, the user and/or healthcare can take corrective measurebased on the information.

The invention may be embodied in other specific forms without departingfrom the spirit or essential characteristics thereof. The foregoingexamples are therefore to be considered in all respects illustrativerather than limiting of the invention described herein. Also, the wordscomprise, include, and/or plural forms of each are open ended andinclude the listed parts and can include additional parts or steps thatare not listed, and the term and/or is open ended and includes one ormore of the listed parts or steps and combinations of the listed partssteps.

What is claimed is:
 1. A drug self-delivery device comprising: ahandheld portion having a proximal end, a distal end and a longitudinalaxis therebetween; a trigger portion in slidable engagement with thedistal end of the handheld portion and defining an injection opening; adrug vial disposed within the handheld portion, the drug vial containinga fluid medication and having a first vial position wherein the drugvial is distal from the trigger portion and a second vial positionwherein the drug vial is proximate to the trigger portion; a needleassembly comprising: a needle having an interior lumen to allow the flowof medication; a needle port for receiving medication from the drugvial; and one or more seals to reduce leakage of medication deliveredfrom the drug vial toward the needle port; a drug delivery portconfigured to deliver medication from the drug vial to the needleassembly when the drug vial is in the second vial position.
 2. The drugself-delivery device of claim 1 wherein the needle assembly has a firstneedle position in which the needle assembly is fully disposed withinthe handheld portion, and a second needle position where at least aportion of the needle extends through the injection opening.
 3. The drugself-delivery device of claim 2 further comprising a penetration springconfigured to transport the needle assembly from the first needleposition to the second needle position when the trigger portion is slidtoward the distal end of the handheld portion.
 4. The drug self-deliverydevice of claim 2 wherein the needle port generally aligns with an exitof the drug delivery port when the needle assembly is in the secondneedle position.
 5. The drug self-delivery device of claim 2 wherein theone or more seals comprises: an upper seal positioned toward theproximal end of the handheld portion relative to the needle port and; alower seal positioned toward the distal end of the handheld portionrelative to the needle port.
 6. The drug self-delivery device of claim 5wherein the lower seal does not move relative to the handheld portion asthe needle assembly transitions between the first needle position andthe second needle position.
 7. The drug self-delivery device of claim 1further comprising a separation strip configured to prevent the triggerportion from sliding toward the distal end of the handheld portion whenthe separation strip is disposed within a gap between the handheldportion and the trigger portion.
 8. The drug self-delivery device ofclaim 7 further comprising a pull ring extending from a point along theseparation strip wherein the pull ring is configured to remove theseparation strip from the gap when pulled perpendicular to thelongitudinal axis of the handheld portion.
 9. The drug self-deliverydevice of claim 8 wherein the handheld portion and the trigger portioncooperate to form a concave outer surface shaped to fit against a user'sappendage for transport such that the longitudinal axis of the handheldportion is generally perpendicular to the appendage.
 10. The drugself-delivery device of claim 9: wherein the pull ring has a storedposition in which it is sandwiched between the concave outer surface andthe user's appendage and a deployed position where the pull ring swingsaway from the concave outer surface; and wherein the pull ringtransitions to the deployed position when the concave outer surface isseparated from the user's appendage.
 11. The drug self-delivery deviceof claim 1 further comprising a communication module and a batterydisposed within the handheld portion.
 12. The drug self-delivery deviceof claim 11 further comprising a separation strip removably connected toan exterior surface of the handheld portion, the separation stripcomprising a non-conductive member extending into the handheld portionthat separates the battery from electrical connection with thecommunication module until the separation strip is removed from thehandheld portion.
 13. The drug self-delivery device of claim 11 whereinwhen the communication module comes into electrical contact with thebattery, the communication module is configured to send a signal to oneor more external communication devices, wherein the communicationcomprises an alert that the drug self-delivery device is in use.
 14. Thedrug self-delivery device of claim 11 further comprising a speaker, andwherein, when the communication module comes into electrical contactwith the battery, the communication module is configured to broadcast apre-recorded instructional message via the speaker.
 15. A method foradministering medication stored within a drug self-delivery devicecomprising the steps of: grasping a handheld portion of the drugself-delivery device having a proximal end, a distal end and alongitudinal axis therebetween and at least partially housing: a drugvial containing a fluid medication to be administered; a needle assemblyhaving a needle port for receiving medication from the drug vial and oneor more seals to reduce leakage of medication delivered from the drugvial; a drug delivery port configured to deliver medication from thedrug vial to the needle assembly; placing a trigger portion of the drugself-delivery device adjacent to a user's skin at a location where themedication is to be administered, the trigger portion being in slidableengagement with the distal end of the handheld portion and defining aninjection opening; and pressing the handheld portion toward the triggerportion such that a portion of the needle extends through the injectionopening.
 16. The method of claim 15 wherein pressing the handheldportion toward the trigger portion causes the needle port toapproximately align with the drug delivery port along a planeperpendicular to the longitudinal axis of the handheld portion.
 17. Themethod of claim 16 wherein the one or more seals comprises an upper sealpositioned toward the proximal end of the handheld portion relative tothe needle port and a lower seal positioned toward the distal end of thehandheld portion relative to the needle port, and wherein pressing thehandheld portion toward the trigger portion causes the upper seal tomove toward the lower seal such that the two seals are closelypositioned on either side of the needle port along the longitudinal axisof the handheld portion.
 18. The method of claim 15 further comprisingthe step of pulling a pull ring to remove a separation strip enablingthe handheld portion to slide relative to the trigger portion along thelongitudinal axis.
 19. The method of claim 18 further comprising thestep of activating a communication module to send an alert signal to aremote communication device identifying that the pull ring has beenremoved.
 20. A drug self-delivery system comprising: a handheldcomponent having a proximal end, a distal end and a longitudinal axistherebetween; a trigger component in slidable engagement with the distalend of the handheld component and defining an injection opening; a drugvial disposed within the handheld component, the drug vial containing afluid medication and having a first vial position wherein the drug vialis distal from the trigger portion and a second vial position whereinthe drug vial is proximate to the trigger portion; a needle assemblycomprising a needle and a needle port, the needle assembly having afirst position where the needle assembly is entirely disposed within thehandheld component and an extended position where the needle is at leastpartially extending through the injection opening; a drug delivery portconfigured to deliver medication from the drug vial to the needleassembly when the needle assembly is in the extended position; and acommunication module configured to send an alert to a remotecommunication device to indicate a state of the drug self-deliverysystem.